Regulatory Focus™ > News Articles > US, EU and Japan Set to Implement New Photosafety Guideline

US, EU and Japan Set to Implement New Photosafety Guideline

Posted 07 January 2014 | By Alexander Gaffney, RAC

The International Conference on Harmonisation (ICH), an international regulatory harmonization group focused on the pharmaceutical sector, has announced that its long-awaited Photosafety Evaluation guideline will soon be implemented by global regulators.

ICH's guidelines are widely followed, and are binding on its three main member regulators: The US Food and Drug Administration (FDA), the EU's European Medicines Agency (EMA) and Japan's Pharmaceutical and Medical Device Agency (PMDA).

As Regulatory Focus has explained in the past, the photosafety guideline, also known as S10, is meant to harmonize photosafety testing standards among the three regions.

Some pharmaceutical products can cause light-induced adverse reactions, including tissue reactions and immune system reactions, under specific conditions. ICH's S10 guideline is intended to consistently establish the testing requirements by which companies need to evaluate the photosafety of their products.

In an announcement on 7 January 2014, ICH said the guideline had been approved by its officials in November 2013, and would now enter the fifth and final step of the ICH process: Implementation.

ICH provided no timeline for implementation.

ICH Statement

Focus Explanation of the S10 Guideline

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